CSL said Friday that the Australian Therapeutic Goods Administration (TGA) has approved the vaccine Gardasil for the prevention of cervical cancer and other conditions caused by the human papillomavirus, and that it will be available in early September by prescription from general practitioners. Gardasil, which is licensed to Merck & Co. and manufactured by CSL, was approved by the FDA earlier this month.
"We can confirm that the TGA have in record-quick time approved the vaccine as being safe for use in Australia so we're pretty happy about that," said CSL spokeswoman Dr. Rachel David, as reported by news sources. She added CSL will liaise with the Australian government about introducing a programme in schools to immunise 12-year-old girls.
CSL is preparing a submission for the pharmaceutical benefits advisory committee for a listing of Gardasil on the Pharmaceutical Benefits Scheme, which would subsidise its costs, The Herald Sun reported. The submission, scheduled for November, will also call for Gardasil to be included on the national immunisation schedule for girls in later primary school and in a catch-up programme for high-school girls and women, aged 18 to 26, who can still benefit from the vaccine.
If the application is successful, the vaccine could be included on the immunisation schedule as early as February 2008.
Australian Medical Association president Mukesh Haikerwal said the vaccine will have limited distribution due to its cost and needs to have universal application to have an effect on mortality rates. "That it'll be available in a sporadic way is better than it not being available at all," he said, as reported by The Sydney Morning Herald. "But to be effective, it needs to be available to all young women to prevent cervical cancer."
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